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User Manual | Users Manual | 1.59 MiB | April 16 2024 | |||
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Label & Label Location | ID Label/Location Info | 263.59 KiB | April 16 2024 | |||
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2.911 (d)(5)(i)(ii) Attestation Statement | Attestation Statements | 24.85 KiB | April 16 2024 | |||
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Antenna Specification | Test Report | 178.55 KiB | April 16 2024 | |||
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1 | User Manual | Users Manual | 1.59 MiB | April 16 2024 |
User Manual Dear customer Thank you for choosing our Hearing Aid The hearing aid is a very sophisticated electronic equipment which is used for hearing compensation for the one who has hearing impaired. This manual will introduce you some basic use methods of hearing aid and the solutions of common problems to help you use hearing aid better. Please read it carefully and regard it as a user guide. With any question, please be free to contact the local hearing center or customer service center. 1 Content 1. Overview .................................................................................................................................... 3 a) Product Feature .................................................................................................................... 3 b) Main Application and Scope ................................................................................................ 3 c) Product Model ...................................................................................................................... 3 d) Environment and Conditions ............................................................................................... 3 e) Impact on the Environment .................................................................................................. 4 f) Safety .................................................................................................................................... 4 2.Structural Characteristics and Operating Principle ............................................................... 4 3.Technical Specification ............................................................................................................... 5 4.Steps for Wearing Hearing Aid and Use ................................................................................... 7 a) Power ON/OFF .................................................................................................................... 8 b) Fit Ear Dome ........................................................................................................................ 9 c) Wear Hearing Aid ............................................................................................................... 10 d) Remove Hearing Aid .......................................................................................................... 11 e) Volume Control/Program Switch ....................................................................................... 12 f) Usage of Application .......................................................................................................... 13 5.Troubleshooting ........................................................................................................................ 17 6.Hearing Aid Maintenance ........................................................................................................ 18 a) Clean Ear Dome ................................................................................................................. 18 b) Clean Hearing Aid .............................................................................................................. 19 c) Anti-Vibration: ................................................................................................................... 20 7.Precautions for Hearing Aid .................................................................................................... 20 a) Dehumidification ................................................................................................................ 20 b) Water Prevention ................................................................................................................ 20 c) High Temperature Prevention ............................................................................................ 21 d) Falling Prevention .............................................................................................................. 21 e) Precautions for Electromagnetic Compatibility ................................................................. 21 f) Others .................................................................................................................................. 27 8.Unpack and Check ................................................................................................................... 27 9.Contraindication ....................................................................................................................... 27 10.Accessories list ........................................................................................................................ 27 11.Symbol Information ............................................................................................................... 28 2 1. Overview This device you choose is the new series hearing aid, rechargeable digital Hearing aid. All main components are from Europe and America with strict production control and accurate test ensuring the excellence quality of each hearing aid. a) Product Feature Digital rechargeable hearing aid is equipped with digital intelligent function, multiple processing channels, intelligent adaptive noise reduction management system and efficient adaptive feedback suppression function etc. This product is not only suitable for listening in a quiet environment but also suitable for a noisy environment. Product appearance design shows a new trend of the hearing aid correspond with human body engineering principle, wearing comfortable and big power. b) Main Application and Scope The BTE hearing aids are a pair of air conduction hearing aids intended for use by individuals 18 years and older with perceived mild to moderate hearing impairment. c) Product Model BTE hearing aid:FH312-B, FH311-B, FH310-B, FH309-B, FH308-B, FH307-B, FH306-B, FH305-B, FH304-B, FH303-B, FH212-B, FH211-B, FH210-B, FH209-B, FH208-B, FH207-B, FH206-B, FH205-B, FH204-B, FH203-B. FH912-B, FH911-B, FH910-B, FH909-B, FH908-B, FH907B, FH906-B, FH905-B, FH904-B, FH903-B, FH812-B, FH811-B, FH810-B, FH809-B, FH808-B, FH807-B, FH806-B, FH805-B, FH804-B, FH803-B,FH712-B, FH711-B, FH710-B, FH709-B, FH708-B, FH707-B, FH706-B, FH705-B,FH704-B, FH703-B, FH612-B, FH611-B, FH610-B, FH609-B, FH608-B, FH607-B, FH606-B,FH605-B,FH604-B,FH603-B,FH512-B,FH511-B,FH510-B, FH509-B,FH508-B,FH507-B, FH506-B, FH505-B, FH504-B, FH503-B, FH412-B, FH411-B, FH410-B, FH409-B, FH408-B, FH407-B, FH406-B, FH405-B, FH404-B, FH403-B BTE hearing aid
:FHE512-B, FHE912-B, FHE712-B, FHE312-B d) Environment and Conditions Working environments Temperature: 0+40 Humidity:0RH80RH Voltage: DC 3.6V Storage environments Temperature:-20+50 Humidity: 0RH93RH Atmospheric pressure: 86KPa106KPa. 3 e) Impact on the Environment The BTE hearing aid is built in the rechargeable Lithium battery, please dispose of the used battery regarding of local regulations to protect the environment. f) Safety Danger: To avoid explosion, please do not put the hearing aids and charging case into fire or microwave oven, and so on. Danger: To avoid being swallowed by children in accident, please keep the hearing aid and charging case away from children. This hearing aids and charging case can only be used by people with hearing loss, the rest cannot be used. Those who have undergone ear canal surgery are not recommended to buy this product directly. They should go to the hearing center to consult with an audiologist or a doctor before purchasing. A hearing aid should not be applied to both ears at the same time. Because the hearing loss of the right or left ear is different. In case of battery leakage, please stop using the hearing aid and contact the customer service center. The patient is also the operator for the device. Only to connect to equipment that conforms with international safety standards, if externally connected. Software controlled fitted OSPL90 shall not exceed the selected value as a result of corrupt data transfer between programmer and Hearing aid. Special User:
1Children cant wear the hearing aid without the guidance of adult. 2Mental patients should consult a physician before wearing a hearing aid. Warning: Hearing aids are able to provide more than 132 dB SPL. The fitted OSPL90 does not increase if the control is disconnected or defective. It neet to the hearing aid professional for RECD measured to correct target of fitted OSPL90. The hearing aids should be fitted by the professional operator otherwise there may be a risk of impairing the remaining hearing of the patient; The hearing aid should be only used by the hearing impaired, not by any other. 2. Structural Characteristics and Operating Principle The product is mainly composed of microphone, signal amplification and processing circuit, receiver, volume control circuit, lithium battery, shell and embedded software. 4 BTE hearing aid (FCC ID: 2A445FH312-B) :
1. Shell 2. Volume Control/Program Switch 3. Microphone 4. Sound Tube 5. Ear Dome (The appearance shall be subject to the actual situation) BTE hearing aid (FCC ID: 2A445FHE512-B) 1. Power ON/OFF 2. Volume Control/Program Switch 3. Shell 4. Microphone 5. Receiver 6. Ear Domes(The appearance shall be subject to the actual situation) 3. Technical Specification 5 Max HFA Peak HFA THD Frequency Equivalent Product Model OSPL90 OSPL90 gain FOG
+3dB
(4dB)
(+3dB)
(5dB) 500H 800H 1600 z z Hz Range(Hz) input noise(+3dB ) Battery Current Drain mA Attack Release Time time
(5mS)
(5m S) FH312-B FH311-B FH310-B FH309-B FH308-B FH307-B FH306-B FH305-B FH304-B FH303-B FH212-B FH211-B FH210-B FH209-B FH208-B FH207-B FH206-B FH205-B FH204-B FH203-B FHE512-B FHE511-B FHE510-B FHE509-B FHE508-B FHE507-B FHE506-B FHE505-B FHE504-B FHE503-B FHE412-B FHE411-B FHE410-B FHE409-B FHE408-B FHE407-B FHE406-B FHE405-B FHE404-B FHE403-B 117 117 117 117 117 117 117 117 117 117 117 117 117 117 117 117 117 117 117 117 117 117 117 117 117 117 117 117 117 117 117 117 117 117 117 117 117 117 117 117 105 105 105 105 105 105 105 105 105 105 103 103 103 103 103 103 103 103 103 103 105 105 105 105 105 105 105 105 105 105 103 103 103 103 103 103 103 103 103 103 35 35 35 35 35 35 35 35 35 35 33 33 33 33 33 33 33 33 33 33 35 35 35 35 35 35 35 35 35 35 33 33 33 33 33 33 33 33 33 33 30 30 30 30 30 30 30 30 30 30 28 28 28 28 28 28 28 28 28 28 30 30 30 30 30 30 30 30 30 30 28 28 28 28 28 28 28 28 28 28 5% 5% 5%
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6 200--5000 200--5000 200--5000 200--5000 200--5000 200--5000 200--5000 200--5000 200--5000 200--5000 200--5000 200--5000 200--5000 200--5000 200--5000 200--5000 200--5000 200--5000 200--5000 200--5000 200--5000
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<29 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 100 100 100 100 100 100 100 100 100 100 100 100 100 100 100 100 100 100 100 100 100 100 100 100 100 100 100 100 100 100 100 100 100 100 100 100 100 100 100 100 500 500 500 500 500 500 500 500 500 500 500 500 500 500 500 500 500 500 500 500 500 500 500 500 500 500 500 500 500 500 500 500 500 500 500 500 500 500 500 500 Response curve BTE hearing aid (FCC ID: 2A445FH312-B) :
7 BTE hearing aid (FCC ID: 2A445FHE512-B) 4. Steps for Wearing Hearing Aid and Use a) Power ON/OFF Power ON:
automatically. BTE hearing aid (FCC ID: 2A445FH312-B):Take the hearing aid out of the charging box and it will turn on BTE hearing aid (FCC ID: 2A445FHE512-B):
Push button DOWN to start working. 8 BTE hearing aid (FCC ID: 2A445FH312-B) BTE hearing aid (FCC ID: 2A445FHE512-B) Power OFF:
BTE hearing aid (FCC ID: 2A445FH312-B) The hearing aid will turn off automatically when it is put into the charging box. BTE hearing aid (FCC ID: 2A445FHE512-B) Push button UP, power is off, hearing aid stop working. BTE hearing aid (FCC ID: 2A445FH312-B) BTE hearing aid (FCC ID: 2A445FHE512-B) Note: Both ends of the charging line are connected with the power adapter and the charging box. Battery life BTE hearing aid (FCC ID: 2A445FH312-B) The hearing aids can work for more than 20H when the battery is fully charged. The full charging case can charge hearing aids 4 times. Model: FAC021, Input: DC5V 500mA, Output: DC4.2V 10mA, Battery: DC3.7V 400mAh 1.48Wh. Power Adapter: Input: 100-240V~50/60Hz, max 150mA, Output: DC5V 1A. BTE hearing aid (FCC ID: 2A445FHE512-B):
The hearing aids can work for more than 20H when the battery is fully charged. The full charging case can charge hearing aids 3 times. 9 Model:FAC018, FAC029, FAC030, FAC031 Input:DC5V 200mA, Output:DC4.2V 50mA, Battery:DC3.7V 300mAh 1.1Wh. Power Adapter: Input: 100-240V~50/60Hz, max 150mA, Output:DC5V 1A. b) Fit Ear Dome Remove Earplugs: Pinch the earplug with your thumb, index finger and middle finger to separate the earplug from the connector. Fit Earplugs: Select appropriate earplug according to the size of the ear canal, hold the earplug and fit it into the connector of the hearing aid. It is required to be fitted in place. c) Wear Hearing Aid Steps:
Hold the bottom of the tube with your fingers and gently push the earplug into the ear canal. 10 Put the hearing aid behind the ear, and close to the head and comfortably over the pinna. If it feels like the dome is falling out of your ear, it means that the dome is most likely too small for your ear. Try changing your dome to one that is a size larger. If it feels like you have to squeeze or force the dome into your ear, it means that the dome is most likely too large for your ear. Try changing your dome to one that is a size smaller. d) Remove Hearing Aid 1. Take off the hearing aid behind the ear. 11 2. Hold the bottom of the sound tube and pull it gently. After the earplug is loose, take it out and take it off together with the hearing aid. e) Volume Control/Program Switch 12 BTE hearing aid (FCC ID: 2A445FH312-B) BTE hearing aid (FCC ID: 2A445FHE512-B) Volume Control/Program Switch Volume Control: Push+ to increase the volume and push-to reduce the volume. Program Switch: Push Volume Control +or -more than 2 seconds, program switching automatically. Kindly explain that user push + to make program switch in positive cycle and user push - to make program switch in reverse cycle. Sleeping Mode or Power ON : Pressing the button for 5 seconds is a sleeping mode, and the hearing aid has no sound output. Press the button for 5 seconds again to wake up the hearing aid and restore normal operation. f) Usage of Application You can use the mobile APP for volume control and program control, which will be more convenient for adjustment. Open the APP in the phone, search for hearing aids, and check available hearing aid 13 devices. User needs to click to confirm the connection. Program switching: Different programs for different models of product. FH312-B, FH310-B, FH308-B, FH306-B, FH304-B, FH212-B, FH210-B, FH208-B, FH206-B, FH204-B, FHE512-B: 3 models: Quiet, Noise, Custom. B FH311-B, FH309-B, FH307-B, FH305-B, FH303-B, FH211-B, FH209-B, FH207-B, FH205-B, FH203-B: 2 models: Quiet and Noise. 14 Volume adjustment: Slide down to decrease the volume and up to increase the volume. Tuning: Click Tuning on the main interface to adjust sound optimizer, FBC, Noise reduction and Attunement. 15 Product setting: You can set reset to default in ear. Language setting: Set app language, including of Traditional Chinese, Simplified Chinese and English. 16 Demonstration mode: Experience how to use the APP without connecting to the product. 5. Troubleshooting Failure Cause Solution Whistling Hearing aid is not worn correctly Wear it correctly again Too much earwax Clean earwax 17 Silent Power off Turn it on Low battery or no power Charging the hearing aid Dirt blocks the earplug or the tube Clean the earplug or the sound tube Small Sound Low volume Turn up the volume Low battery power Charge the hearing aid Hearing aid is damped Dehumidify it with a dry box Dirt blocking the sound tube or the Clean the sound tube or the earplug earplugs High Power Hearing aid is still on when not in use Please turn it off when hearing aid is not in use Consumption Hearing aid is damped Dehumidify it with a dry box Intermittent Dirt blocks the sound tube Clean the sound tube Sound Dirt blocks the earplugs Clean the earplugs If the above methods still cannot solve the problem, please contact the fitting center where you purchased the hearing aid, or directly contact the customer service center of our company. 6. Hearing Aid Maintenance During the use of hearing aid, earwax (cerumen) produced by the ears will accumulate in the ear canal and the sound hole of the hearing aid. A large amount of accumulated earwax will affect the use effect of the hearing aid, so please clean your ear canal and maintain the hearing aid regularly. a) Clean Ear Dome Remove the ear dome from the hearing aid. 18 Clean the earwax with a cleaning cloth or wash the ear dome with clean water. Please wipe the ear dome dry and make sure there is no water droplets left. If there are tools like a blowing balloon, you can use a blowing balloon to dry the water droplets. b) Clean Hearing Aid Please use the small brush to clean the earwax of the sound hole of the hearing aid. Please clean your hearing aid with a dry soft cloth. 19 When wiping or cleaning the hearing aid, please do it on a soft desktop (for example, put a soft towel on the desktop) to avoid damage caused by accidental falling of the hearing aid. Remember: Do not use any liquid to clean the hearing aid. c) Anti-Vibration:
If you dont use them when going out, please put the hearing aid in the shockproof box or shockproof bags. 7. Precautions for Hearing Aid a) Dehumidification Any form of moisture is influential for hearing aid, dehumidification can extend the life of the hearing aid. Avoid using or storage in humid environment, and please dry the hearing aid on a regular basis. b) Water Prevention Avoid hearing aid contact with water. Remove the hearing aid when you are swimming, taking a shower, washing your hair, and washing your face. If hearing aid accidentally falls into the water, do not use dryer to dry it. You can dry it with a soft, clean cotton cloth and put it in a ventilated environment. If a failure occurs, please contact with the staff from customer service center. 20 c) High Temperature Prevention Never exposing hearing aid on extreme temperatures or prolonged exposure to sunlight. d) Falling Prevention Please do not drop your hearing aid or knock them against hard surfaces. e) Precautions for Electromagnetic Compatibility Classification by anti electric shock type: Internal power supply equipment. Classification according to the degree of protection against electric shock: Type B application part. For hearing aids that do not comply with requirements for explosive or oxygenenriched atmospheres: warning not to use the hearing aids in such areas. For hearing aids with wireless transmission: warning to check first before using the hearing aids system in areas where electronics or wireless devices are restricted. Classification by operation mode: Continuous operation equipment. Notes: The In-The-Ear Hearing Aid conforms to IEC60601-1-2 EMC requirements. It is the responsibility of the user to ensure the electromagnetic compatibility environment of the instrument to function properly. User must install and operate the device based on the provided EMC information. It is recommended to evaluate the electromagnetic environment before using the instrument to ensure that the surrounding environment will not cause strong electromagnetic interference to the instrument, otherwise it may interfere with the normal operation of the equipment. Instructions for use: The ME EQUIPMENT or ME SYSTEM is suitable for healthcare environments and so on. Warning: Only the power adapter and battery approved by manufacturer can be used. In order to avoid damage to the instrument, please do not change the charging parts. Even if other devices meet the emission requirements of the corresponding national standards, the In-The-Ear Hearing Aid may still be interfered by other devices. 21 Warning: In the home environment, this equipment may cause radio interference, so protective measures should be taken. It is forbidden to use the equipment near strong radiation source (such as unshielded RF source), otherwise it may interfere with the normal operation of the equipment. Warning: Portable or mobile RF communication device might influence the performances of In-The-Ear Hearing Aid, please avoid strong electromagnetic disturbance while using, such as close to the In-The-Ear Hearing Aid, microwave oven, etc . Warning: Use of this equipment adjacent to or stacked with other equipment should be avoided because it could result in improper operation. If such use is necessary, this equipment and the other equipment should be observed to verify that they are operating normally. Warning: Portable RF communications equipment (including peripherals such as antenna cables and external antennas) should be used no closer than 30 cm (12 inches) to any part of the In-The-Ear Hearing Aid, including cables specified by the manufacturer. Otherwise, degradation of the performance of this equipment could result. Warning: Use of accessories, transducers and cables other than those specified or provided by the manufacturer of this equipment could result in increased electromagnetic emissions or decreased electromagnetic immunity of this equipment and result in improper operation. Warning: Do not approach active high-frequency surgical equipment and magnetic resonance imaging systems in radiofrequency shielded rooms, where the intensity of EMI disturbances is high. Warning: Do not near active HF surgical equipment and the RF shielded room of an ME system for magnetic resonance imaging, where the intensity of EM disturbances is high. Warning: Make sure that all electrical accessories connected to the In-The-Ear Hearing Aid must comply with IEC 60601-1, if in doubt, consult the technical service department or your local representative. Warning: No unauthorized modification allowed of the ME EQUIPMENT. According to the design purpose, the equipment complies with EMC regulations. Including the allowable electromagnetic level and necessary electromagnetic shielding performance of the electronic equipment specified by laws and regulations. interference The complete elimination of electromagnetic interference is almost impossible unless all equipment that may produce high-frequency signals are excluded. Although some high-frequency equipment itself meets the requirements of EMC regulations, it is impossible to determine whether the radio signal generated by its high-frequency transmitter will affect the normal operation of the equipment when it works with considerable power near the equipment order to ensure the electromagnetic compatibility of the equipment, the equipment needs to be installed, debugged and used according to the attached documents. In case of such situation, please contact the personnel of the company for solution. This equipment generates, uses, and can radiate RF energy and, if not installed and used in accordance with the instructions, may cause harmful interference to radio communications. However, there is no guarantee that interference will not occur in a particular installation. If this equipment does cause harmful interference to radio or television reception, which can be 22 determined by turning the equipment off and on, the user is encouraged to try to correct the interference by one or more of the following measures:
- Operate in strict accordance with the instructions of the In-The-Ear Hearing Aid instruction manual to ensure that the device is not subject to electromagnetic interference.
- Keep other devices away from this device to reduce the effects of electromagnetic interference.
- Reorient or relocate the receiving antenna. The effect of electromagnetic interference can be mitigated by adjusting the relative position/mounting angle between the device and other devices.
- Reduce electromagnetic interference by changing the wiring location of other device power/signal cables.
- Reduce electromagnetic interference by changing the power path of other devices. Table 1 Guidance and manufacturers declaration-electromagnetic emission The In-The-Ear Hearing Aid is intended for use in the electromagnetic environment specified below. The customer or the user of the In-The-Ear Hearing Aid should assure that it is used in such an environment. Emissions test Compliance Electromagnetic environment-guidance The In-The-Ear Hearing Aid uses RF energy only for its internal function. Therefore, its RF emissions are very low and are not likely to cause any interference in nearby electronic equipment. The In-The-Ear Hearing Aid suitable for use in all establishments, including domestic establishments and those directly connected to the public low-voltage power supply Group 1 Class B Class A Complies network that supplies buildings used for domestic purposes. RF emissions CISPR 11 RF emissions CISPR 11 Harmonic emissions IEC61000-3-2 Voltage fluctuations/flicker emissions IEC61000-3-3 Table 2 Guidance and manufacturers declaration-electromagnetic The In-The-Ear Hearing Aid is intended for use in the electromagnetic environment specified below. The customer or the user of the In-The-Ear Hearing Aid should assure that it is used in such an environment. Immunity test IEC60601 test level Compliance Electromagnetic environment level
-guidance Electrostatic 8 kV contact 8 kV contact Floors should be wood, concrete discharge(ESD) 2, 4, 8, 15 kV air 2, 4, 8, 15 kV or ceramic tile. if floors are 23 IEC61000-4-2 air covered with synthetic material, the relative humidity should be at least 30%
2 kV for power Electrical fast transient/
supply lines 2 kV for burst 1 kV for power N/A IEC61000-4-4 input/output supply lines lines 1 kV differential Surge mode IEC 61000-4-5 2 kV common mode Dips:
1 kV differential N/A mode Dips:
Voltage dips, short interruptions and voltage variations on power supply input lines IEC61000-4-11 0% UT for 0.5 cycle at 0, 45,90,135,18 0,225,270 and 315 0% UT for 0.5 cycle at 0, 45,90,135
,180,225
,270 and 315 0% UT for 1 cycle at 0 0% UT for 1 cycle at 0 70% UT for 25 cycles50Hz, 30 cycles60Hzat 0 Interruptions:
0% UT for 250 cycles50Hz, 300 cycles60Hz 70% UT for 25 cycles50Hz, N/A 30 cycles 60Hzat 0 Interruptions:
0% UT for 250 cycles50Hz, 300 cycles 60Hz Power frequency(
Power frequency magnetic fields should be at levels characteristic 50Hz/60Hz) magnetic field 30A/m 30A/m of a typical location in a typical IEC61000-4-8 commercial or hospital environment. NOTE: UT is the a.c. mains voltage prior to application of the test level. Table 3 Guidance and manufacturers declaration electromagnetic immunity The In-The-Ear Hearing Aid is intended for use in the electromagnetic environment specified below. The customer or the user of The In-The-Ear Hearing Aid should assure that it is used in such an electromagnetic environment. Immunity test IEC60601 test level Compliance level 24 Electromagnetic environment
-guidance Portable and mobile RF communications equipment should Conducted RF IEC61000-4-6 Radiated RF IEC61000-4-3 be used no closer to any part of The In-The-Ear Hearing Aid, including cables, than the recommended separation distance 0,15MHz80MHz 0,15MHz80MHz calculated from the equation 3 V RMS outside the ISM band, c) 6 V RMS in the ISM and amateur radio bands d) 3 V RMS outside the ISM band, c)6 V RMS in the ISM and amateur radio bands d) applicable to the frequency of the transmitter. Recommended separation distance d=1.2 P d=1.2 P 80MHz to 800MHz d=2.3 P 800MHz to 2.5GHz Where P is the maximum output power rating of the transmitter in watts
(W) according to the transmitter manufacturer and d is the recommended separation 10V/m 10V/m distance in meters (m). 80 MHz to 2.7 GHz 80 MHz to 2.7 GHz Field strengths from fixed RF electromagnetic site survey transmitters, as determined by an
,a) should be less than the compliance level in each frequency range .b) Interference may occur the in vicinity of equipment marked with the following symbol. NOTE 1: At 80 MHz and 800 MHz, the higher frequency range applies. NOTE 2: These guidelines may not apply in all situations. Electromagnetic propagation is affected by absorption and reflection from structures, objects and people. a: Field strengths from fixed transmitters, such as base stations for radio (cellular / cordless) telephones and land mobile radios, amateur radio, AM and FM radio broadcast and TV broadcast cannot be predicted theoretically with accuracy. To assess the electromagnetic environment due to fixed RF transmitters, and electromagnetic site survey should be considered. If the measured field strength in the location in which The In-The-Ear Hearing Aid is used exceeds the applicable RF compliance level above, The In-The-Ear Hearing Aid should be observed to verify normal operation. If abnormal performance is observed, additional measures may be necessary, such as re-orienting or relocating The In-The-Ear Hearing Aid. b: Over the frequency range 150 kHz to 80 MHz, field strengths should be less than 3V/m. c:ISM bands between: 6.765MHz~6.795 MHz, 13.553 MHz~13.567 MHz, 26.957 MHz~27.283 MHz, 40.66 MHz~40.70 MHz d:ama-teur radio bands between: 1.8MHz~2.0MHz, 3.5MHz~4.0MHz, 5.3MHz~5.4MHz, 7MHz~7.3MHz, 10.1MHz~10.15MHz, 14MHz~14.2MHz, 18.07MHz~18.17MHz, 21.0MHz~21.4MHz, 24.89MHz~24.99MHz, 28.0MHz~29.7MHz, 50.0MHz~54.0MHz 25 Table 4 Frequency Range and Level: RF wireless communication equipment Test Frequency
(MHz) 385 450 710 745 780 810 870 930 1720 1845 1970 2450 5240 5500 5785 ATTENTION:
Modulation immunity Level Applied (V/m) Minimum immunity Level 18Hz PM 50%
1 kHz sine FM + 5 Hz deviation 217Hz PM 50%
18Hz PM 50%
217Hz PM 50%
217Hz PM 50%
217Hz PM 50%
(V/m) 27 28 9 28 28 28 9 27 28 9 28 28 28 9 If necessary to achieve the IMMUNITY TEST LEVEL, the distance between the transmitting antenna and the ME EQUIPMENT or ME SYSTEM may be reduced to 1 m. The 1 m test distance is permitted by IEC 61000-4-3. a) For some services, only the uplink frequencies are included Table 5 Recommended separation distances between portable and mobile RF communication the equipment The In-The-Ear Hearing Aid is intended for use in an electromagnetic environment in which radiated RF disturbances are controlled. The customer or the user of The In-The-Ear Hearing Aid can help prevent electromagnetic interference by maintaining a minimum distance between portable and mobile RF communications equipment (transmitters) and the In-The-Ear Hearing Aid as recommended below, according to the maximum output power of the communications equipment. Rated maximum output power of transmitter Separation distance according to frequency of transmitter M(Meters) 150kHz to 80MHz 80MHz to 800MHz 80MHz to 2,5GHz W(Watts) d=1.2 P d=1.2 P d=2.3 P 0,01 0,1 1 10 100 N/A N/A N/A N/A N/A 0.12 0.38 1.2 3.8 12 0.23 0.73 2.3 7.3 23 For transmitters rated at a maximum output power not listed above, the recommended separation distance in meters (m) can be determined using the equation applicable to the frequency of the transmitter, where P is the maximum output power rating of the transmitter in watts (W) according to the transmitter manufacturer. NOTE 1 : At 80 MHz and 800 MHz, the separation distance for the higher frequency range applies. 26 NOTE 2 : These guidelines may not apply in all situations. Electromagnetic propagation is affected by absorption and reflection from structures, objects and people. f) Others Keep the outer surface of the hearing aid clean, and often clean the earwax in the earplug. The Hearing aids should be sent to the fitting center for maintenance and inspection regularly to ensure that the hearing aids are in good condition. The touch button should be used correctly and pressed gently as far as possible to avoid excessive force. When the hearing aid is not used for a long time, the hearing aid should be put back into the charging box for shutdown. 8. Unpack and Check After unpacking, please check the actual category and quantity of accessories. Check the model marked on the manual is consistent with the model of hearing aid. 9. Contraindication Patients with acute otitis external, tympanitis, chronic suppurative otitis media (in the period of purulent infection), acute suppurative otitis media and allergic to this material. Fitting hearing aid shall be undergone professional hearing test and fitting, and be used under the professional guidance of a doctor or a audiologist. 10. Accessories list BTE hearing aid:
27 Accessories List Number Unit Ear domes User manual Certification Warranty card Charger case Type-C cable Cleaning tool Cerumen cleaning strip BTE-RIC:
1 1 1 1 1 1 1 1 PC PC PC PC PC PC PC PC Accessories List Number Unit Ear domes User manual Certification Warranty card Charger case Type-C cable Cleaning tool Cerumen cap suit 11. Symbol Information Symbol for User Guide must be read Symbol for Manufacturer Symbol for Fragile, handle with care PC PC PC PC PC PC PC PC Symbol for Consult instructions for use Symbol for Keep dry Symbol for Serial number 1 1 1 1 1 1 1 1 28 Symbol for Caution and warning Symbol for Date of manufacture IP22 Symbol for Use-by date This marking shown on the product or its literature, indicates that it should not be disposed of, with other household wastes at the end of its working life. To prevent possible harm to the environment or human health from uncontrolled waste disposal, please separate this from other types of wastes and recycle it responsibly to promote the sustainable reuse of material resources. During transport or storage, the temperature should not exceed the limit values of -20 to 50 Celsius for a long period of time. The air pressure range between 86 and 106 KPa is appropriate. Type B Applied Part IP22: The first number 2:
Protected against solid foreign objects of 12,5 mm and greater. The second number: Protected against vertically falling water drops when enclosure titled up to 15. The harmful substances in the product meet the limited requirements. During transport or storage, the relative humidity should not exceed the limit values of 0% to 93% for a long period of time. 29 FCC Statement:
Any Changes or modifications not expressly approved by the party responsible for compliance could void the users authority to operate the equipment. This device complies with part 15 of the FCC Rules. Operation is subject to the following two conditions:
(1) This device may not cause harmful interference, and
(2) This device must accept any interference received, including interference that may cause undesired operation. The device has been evaluated to meet general RF exposure requirement. The device can be used in portable exposure condition without restriction. Note: This equipment has been tested and found to comply with the limits for a Class B digital device, pursuant to part 15 of the FCC Rules. These limits are designed to provide reasonable protection against harmful interference in a residential installation. This equipment generates, uses and can radiate radio frequency energy and, if not installed and used in accordance with the instructions, may cause harmful interference to radio communications. However, there is no guarantee that interference will not occur in a particular installation. If this equipment does cause harmful interference to radio or television reception, which can be determined by turning the equipment off and on, the user is encouraged to try to correct the interference by one or more of the following measures:
Reorient or relocate the receiving antenna. Increase the separation between the equipment and receiver. Connect the equipment into an outlet on a circuit different from that to which the receiver is connected. Consult the dealer or an experienced radio/TV technician for help. 19 Manufacturer: Austar Hearing Science and Technology (Xiamen) Co., Ltd. Address: B8, Biomedical Industrial Park, NO.2064 Wengjiao West Road, Haicang Dist., Xiamen, Fujian, China Postcode: 361028 Tel: +86-592-5900230 Fax: +86-592-5621123 Preparation date: 2022.11 30
1 | Label & Label Location | ID Label/Location Info | 263.59 KiB | April 16 2024 |
4mm 24mm
+ AUSTAR SN:XXXXXXXX Model: FACO18 Input: DC5V=200mA Output: DC4.2V=50mA Battery: DC36V 300mAh 1.1Wh FCC ID:2A445FHE512-B Web: www.austar-hearing.net Made in China CES, 2023-01 23.6mm AUSTAR SN:XXXXXXXX Model: FACO18 Input: DCSV=200mA Output: DC4,.2V=50mA Battery: DC36V 300mAh 1.1Wh FCC ID:2A445FHES12-B Web: www.austar-hearing.net Made in China
1 | 2.911 (d)(5)(i)(ii) Attestation Statement | Attestation Statements | 24.85 KiB | April 16 2024 |
Austar Hearing Science and Technology (Xiamen) Co., Ltd. Add: B8, Biomedical Industrial Park, NO.2064 Wengjiao West Road, Haicang Dist., Xiamen, Fujian, China Tel: +86-18650110816 Fax: +86-0592-5970067 E-mail: yangyiqun@austar-hearing.com Attestation Letter Date: 2024-03-04 FEDERAL COMMUNICATIONS COMMISSIONS Authorization and Evaluation Division 7435 Oakland Mills Road Columbia, MD 21046 Ref: Attestation Statements CFR 47 2.911(d)(5)(i)(ii) Filing FCC ID: 2A445FHE512-B Austar Hearing Science and Technology (Xiamen) Co., Ltd. (the applicant) certifies that the equipment for which authorization is sought is not covered equipment prohibited from receiving an equipment authorization pursuant to section 2.903 of the FCC rules. Austar Hearing Science and Technology (Xiamen) Co., Ltd. (the applicant) certifies that as of the date of the filing of the application, the applicant is not identified on the Covered List as an entity producing covered equipment. Sincerely, Signature Contact Person: Ula Yang Title: RA Engineer CFR 47 2.911(d)(5)(i)(ii) Attestation Letter
1 | Attestation Letter | Attestation Statements | 52.82 KiB | April 16 2024 |
Austar Hearing Science and Technology (Xiamen) Co., Ltd. Address: B8, Biomedical Industrial Park, NO.2064 Wengjiao West Road, Haicang Dist., Xiamen, Fujian, China TEL: 18650110816 Fax: +86-0592-5970067 E-mail: yangyiqun@austar-hearing.com Attestation Letter Date: 2024-03-08 FEDERAL COMMUNICATIONS COMMISSION Authorization and Evaluation Division 7435 Oakland Mills Road Columbia, MD 21046 Dear Sir or Madam:
The RF chip installed in our product BTE Hearing-aid (model name: FHE512-B, FHE912-B, FHE712-B, FHE312-B, FCC ID: 2A445FHE512-B), only BLE 1M (GFSK) functions was activated, the other functions are disabled by using the software and the end user cannot activate them. Please contact me if there is need for any additional clarification or information. Best Regards, Sincerely Yours, Signature:
Contact Person: Ula Yang Title: RA Engineer
1 | Declaration Letter | Attestation Statements | 148.49 KiB | April 16 2024 |
Austar Hearing Science and Technology (Xiamen) Co., Ltd. Add: B8, Biomedical Industrial Park, NO.2064 Wengjiao West Road, Haicang Dist., Xiamen, Fujian, China Tel: +86-18650110816 Fax: +86-0592-5970067 E-mail: yangyiqun@austar-hearing.com Date: 2024-03-04 FEDERAL COMMUNICATIONS COMMISSION Authorization and Evaluation Division 7435 Oakland Mills Road Columbia, MD 21046 Dear Sir/Madam, We, Austar Hearing Science and Technology (Xiamen) Co., Ltd. hereby authorize Bay Area Compliance Laboratories Corp. (Dongguan) to act as a laboratory for testing and test report generation for the following project(s):
(Product description: BTE hearing aid, model: FHE512-B, FHE912-B, FHE712-B, FHE312-B, FCC ID: 2A445FHE512-B) The right headset and left headset are come with the same circuit diagram, PCB layout and key components. Right Board Left Board Sincerely, Signature:
Contact Person: Ula Yang Title: RA Engineer
1 | DoS Letter | Cover Letter(s) | 41.82 KiB | April 16 2024 |
Austar Hearing Science and Technology (Xiamen) Co., Ltd. Add: B8, Biomedical Industrial Park, NO.2064 Wengjiao West Road, Haicang Dist., Xiamen, Fujian, China Tel: +86-18650110816 Fax: +86-0592-5970067 E-mail: yangyiqun@austar-hearing.com DECLARATION OF SIMILARITY Date: 2024-03-04 FEDERAL COMMUNICATIONS COMMISSION Authorization and Evaluation Division 7435 Oakland Mills Road Columbia, MD 21046 Dear Sir or Madam:
We, Austar Hearing Science and Technology (Xiamen) Co., Ltd., hereby declare that the product: BTE Hearing-aid, FCC ID: 2A445FHE512-B. Model: FHE912-B, FHE712-B, FHE312-B are electrically identical with the model: FHE512-B which was tested by Bay Area Compliance Laboratories Corp.
(Dongguan) with the same electromagnetic emissions and electromagnetic compatibility characteristics. A description of the differences between those models and that are declared similar are as follows:
Tested Model Series Models Difference FHE512-B FHE912-B FHE712-B FHE312-B Model name, Appearance and Charging Box Model name, Appearance and Charging Box Model name, Appearance and Charging Box Please contact me should there be need for any additional clarification or information. Best Regards, Signature:
Printed Name: Ula Yang Title: RA Engineer
1 | FCC Agent Authorization Letter | Cover Letter(s) | 66.77 KiB | April 16 2024 |
Austar Hearing Science and Technology (Xiamen) Co., Ltd. Add: B8, Biomedical Industrial Park, NO.2064 Wengjiao West Road, Haicang Dist., Xiamen, Fujian, China Tel: +86-18650110816 Fax: +86-0592-5970067 E-mail: yangyiqun@austar-hearing.com FCC Authorization Date: 2024-03-08 FEDERAL COMMUNICATIONS COMMISSION Authorization and Evaluation Division 7435 Oakland Mills Road Columbia, MD 21046 Subject: Agent Authorization To whom it may concern:
We , Austar Hearing Science and Technology (Xiamen) Co., Ltd., Hereby authorizes Bay Area Compliance Laboratories Corp. (Dongguan) to act on its behalf in all matters relating to application for Equipment authorization, including the signing of all documents relating to these matters. All acts carried out by Bay Area Compliance Laboratories Corp.
(Dongguan) on our behalf shall have the same effect as our own action. We, the undersigned, hereby certify that we are not subject to a denial of federal benefits, that includes FCC benefits, pursuant to Section 5301 of the Anti-Drug Abuse Act of 1988, 21 U.S.C. 862. This authorization is valid until further written notice from the applicant. Sincerely Yours, Clients signature Contact Person: Ula Yang Title: RA Engineer QA-FR-170-B
1 | FCC Long-term Confidential Request | Cover Letter(s) | 37.57 KiB | April 16 2024 |
Austar Hearing Science and Technology (Xiamen) Co., Ltd. Add: B8, Biomedical Industrial Park, NO.2064 Wengjiao West Road, Haicang Dist., Xiamen, Fujian, China Tel: +86-18650110816 Fax: +86-0592-5970067 E-mail: yangyiqun@austar-hearing.com FCC Confidential Authorization Date: 2024-03-04 FEDERAL COMMUNICATIONS COMMISSIONS Authorization and Evaluation Division 7435 Oakland Mills Road Columbia, MD 21046 Subject: Confidentiality Request regarding application for certification of FCC ID:2A445FHE512-B In accordance with Sections 0.457 and 0.459 of the Commissions Rules, Austar Hearing Science and Technology (Xianmen) Co., Ltd. hereby requests long-term confidential treatment of information accompanying this application as outlined below:
Block Diagram Schematics Operation Description The above materials contain proprietary and confidential information not customarily released to the public. The public disclosure of these materials provides unjustified benefits to its competitors in the market. Sincerely, Signature:
Contact Person: Ula Yang Title: RA Engineer QA-FR-171-A
1 | Label Placement Cover letter | Cover Letter(s) | 307.29 KiB | April 16 2024 |
Austar Hearing Science and Technology (Xiamen) Co., Ltd. Add: B8, Biomedical Industrial Park, NO.2064 Wengjiao West Road, Haicang District, Xiamen, Fujian, China Tel: +86-18650110816 Fax: +86-0592-5970067 Email: yangyiqun@austar-hearing.com DECLARATION OF SIMILARITY Date: 2024-03-04 FEDERAL COMMUNICATIONS COMMISSION Authorization and Evaluation Division 7435 Oakland Mills Road Columbia, MD 21046 Dear Sir or Madam:
We, Austar Hearing Science & Technology (Xiamen) Co., Ltd. , product: TWS EARBUDS, hereby submits FCC ID: 2A445FHE512-B justification for placing the FCC ID label to Charge box. According to the FCC Regulation and Guidence (KDB Publication 784748 D01 v09R01) allows for the FCC ID to be removed to Charge box if the device is Unquestionably too small for the FCC ID label to be printed. The measurement of headset: Length (29.4mm)*Width (18.5mm)*High (8.5mm), The label width is 23.5mm, Referring to the above quote, as the headset are too small for the FCC ID label to be printed, so the FCC ID label will be moved to the Charge box. Below photo will show the detail:
Headset Dimension:
Label Dimension:
Charge box Dimension:
Signature:
Printed Name: Ula Yang Title: RA Engineer
1 | US Agent Attestation Letter | Attestation Statements | 78.19 KiB | April 16 2024 |
U.S. AGENT LETTER OF ATTESTATION Date: 2024-03-04 FEDERAL COMMUNICATIONS COMMISSION Authorization and Evaluation Division 7435 Oakland Mills Road Columbia, MD 21046 Ref: Attestation Statements CFR 47 2.911(d)(7) Filing FCC ID: 2A445FHE512-B Austar Hearing Science and Technology (Xiamen) Co., Ltd. (the Applicant) certifies that, as of the date of the filing of the application, Iconsigh Inc. is our designated U.S. agent for service of process for the above referenced FCC ID. Austar Hearing Science and Technology (Xiamen) Co., Ltd. (the Applicant) accepts to maintain an agent for no less than one year after the grantee has terminated all marketing and importation or the conclusion of any Commission-related proceeding involving the equipment. Iconsigh Inc. accepts, as of the date of the filing of the application, the obligation of the designated U.S. agent for service of process for the above referenced FCC ID. Designated U.S. Agent Information:
Company Name: Iconsigh Inc. Address: 2310 Homestead Road, Suite C1, Los Altos, CA, 94024, USA FRN: 0033398652 Tel.: +1 (408) 320-9867 Email: benjamin.kaur@iconsigh.com Signed by (printed name): Benjamin Kaur Signature:
Applicant: Austar Hearing Science and Technology (Xiamen) Co., Ltd. Address: B8, Biomedical Industrial Park, NO.2064 Wengjiao West Road, Haicang Dist., Xiamen, Fujian, China FRN: 0031993454 Tel: +86-18650110816 Email: yangyiqun@austar-hearing.com Signed by (printed name): Ula Yang Signature:
frequency | equipment class | purpose | ||
---|---|---|---|---|
1 | 2024-04-16 | 2402 ~ 2480 | DTS - Digital Transmission System | Original Equipment |
app s | Applicant Information | |||||
---|---|---|---|---|---|---|
1 | Effective |
2024-04-16
|
||||
1 | Applicant's complete, legal business name |
Austar Hearing Science and Technology (Xiamen) Co., Ltd.
|
||||
1 | FCC Registration Number (FRN) |
0031993454
|
||||
1 | Physical Address |
B8, Biomedical Industrial Park, No.2064 Wengjiao West Road, Haicang Dist.
|
||||
1 |
B8, Biomedical Industrial Park
|
|||||
1 |
Xiamen, Fujian, N/A
|
|||||
1 |
China
|
|||||
app s | TCB Information | |||||
1 | TCB Application Email Address |
b******@baclcorp.com
|
||||
1 | TCB Scope |
A4: UNII devices & low power transmitters using spread spectrum techniques
|
||||
app s | FCC ID | |||||
1 | Grantee Code |
2A445
|
||||
1 | Equipment Product Code |
FHE512-B
|
||||
app s | Person at the applicant's address to receive grant or for contact | |||||
1 | Name |
U**** Y********
|
||||
1 | Title |
RA Engineer
|
||||
1 | Telephone Number |
18650********
|
||||
1 | Fax Number |
+86-0********
|
||||
1 |
y******@austar-hearing.com
|
|||||
app s | Technical Contact | |||||
n/a | ||||||
app s | Non Technical Contact | |||||
n/a | ||||||
app s | Confidentiality (long or short term) | |||||
1 | Does this application include a request for confidentiality for any portion(s) of the data contained in this application pursuant to 47 CFR § 0.459 of the Commission Rules?: | Yes | ||||
1 | Long-Term Confidentiality Does this application include a request for confidentiality for any portion(s) of the data contained in this application pursuant to 47 CFR § 0.459 of the Commission Rules?: | No | ||||
if no date is supplied, the release date will be set to 45 calendar days past the date of grant. | ||||||
app s | Cognitive Radio & Software Defined Radio, Class, etc | |||||
1 | Is this application for software defined/cognitive radio authorization? | No | ||||
1 | Equipment Class | DTS - Digital Transmission System | ||||
1 | Description of product as it is marketed: (NOTE: This text will appear below the equipment class on the grant) | BTE hearing aid | ||||
1 | Related OET KnowledgeDataBase Inquiry: Is there a KDB inquiry associated with this application? | No | ||||
1 | Modular Equipment Type | Does not apply | ||||
1 | Purpose / Application is for | Original Equipment | ||||
1 | Composite Equipment: Is the equipment in this application a composite device subject to an additional equipment authorization? | No | ||||
1 | Related Equipment: Is the equipment in this application part of a system that operates with, or is marketed with, another device that requires an equipment authorization? | No | ||||
1 | Grant Comments | Power listed is conducted. | ||||
1 | Is there an equipment authorization waiver associated with this application? | No | ||||
1 | If there is an equipment authorization waiver associated with this application, has the associated waiver been approved and all information uploaded? | No | ||||
app s | Test Firm Name and Contact Information | |||||
1 | Firm Name |
Bay Area Compliance Laboratories Corp. (Dongguan)
|
||||
1 | Name |
D****** Z********
|
||||
1 | Telephone Number |
0086-********
|
||||
1 |
q******@baclcorp.com
|
|||||
Equipment Specifications | |||||||||||||||||||||||||||||||||||||||||
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Line | Rule Parts | Grant Notes | Lower Frequency | Upper Frequency | Power Output | Tolerance | Emission Designator | Microprocessor Number | |||||||||||||||||||||||||||||||||
1 | 1 | 15C | 2402.00000000 | 2480.00000000 | 0.0020000 |
some individual PII (Personally Identifiable Information) available on the public forms may be redacted, original source may include additional details
This product uses the FCC Data API but is not endorsed or certified by the FCC